The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port M.r.i. Dual Lumen Vascular Access Syst..
| Device ID | K921201 |
| 510k Number | K921201 |
| Device Name: | VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-12 |
| Decision Date | 1992-07-21 |